WO2000069508A1

WO2000069508A1 - Variable rate infusion apparatus with indicator and adjustable rate control

Info

Publication number: WO2000069508A1
Application number: PCT/US2000/012941
Authority: WO
Inventors: Kriesel S. Marshall; Thomas N. Thompson
Original assignee: Science Inc
Current assignee: Science Inc
Priority date: 1999-05-14
Filing date: 2000-05-11
Publication date: 2000-11-23
Anticipated expiration: 2001-11-14
Also published as: AU5004600A; US6183441B1

Abstract

This invention is an apparatus (30) for accurately infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time. The apparatus (30) is of a compact, low profile, laminate construction, includes an elastic distended membrane (86), and a chamber having a fluid outlet (118). The apparatuss (30) also includes a highly novel fluid flow indicator (36) that provides a readily discernible visible indication of fluid flow through the apparatus (30). Additionally, the apparatus (30) includes a novel adjustable flow rate control means (34) for precisely adjustably controlling the rate of fluid flow from the reservoir (82) of the device.

Description

VARIABLE RATE INFUSION APPARATUS WITH INDICATOR AND ADJUSTABLE RATE CONTROL

SPECIFICATION

Background of the Invention

This is a Continuation-In-Part of co-pending United States Application

Serial No. 09/165,713 filed October 2, 1998 which is a Continuation-In-Part of

co-pending United States application Serial No. 08/768,663 filed December 18,

1996.

Field of the Invention

The present invention relates generally to fluid delivery devices. More par¬

ticularly, the invention concerns an improved apparatus for infusing medicinal

agents into an ambulatory patient at specific rates over extended periods of time,

which apparatus includes fluid flow indicator means and a novel adjustable flow

rate control means for precisely adjustably controlling the rate of fluid flow from

the reservoir of the device.

Discussion of the Prior Art

The biotechnology industry emerged in the 1980s as new molecular biologi¬

cal techniques made possible the commercial production of proteins, peptides and

other biopharmaceuticals These molecules are integral to numerous physiological processes and have enormous therapeutic potential as oncolytics hormones, anal¬

gesics,

growth factors and other It is believed that at the pres¬

ent time there are currently over 600 biotech drugs m advanced stages of develop¬

ment

Because bioengmeered molecules often have an extremely short biological

half-life and poor bioavailabi ty, continuous infusion is often considered to be a

more economically and therapeutically practical route of drug delivery than oral,

ocular, nasal, buccal, intestinal, rectal or pulmonary administration As will be

better appreciated from the discussion which follows, the apparatus of the present

invention has been specifically engineered for these emerging therapies and will

allow highly safe and accurate microscaled ambulatory infusion of drugs with nar¬

row therapeutic windows In one form of d e invention, the apparatus will accept

either 1 5 or 3 0 mL vial cartridges of mjectable agent, consistent with the expected

dosmg requirements of many biopharmaceuticals now under development

Many of the pharmacologic agents now under development possess a very

narrow range of therapeutic effectiveness, for instance, too small a dose results m

no effect, while too great a dose results in toxic reaction Additionally, the ever

increasing medicinal use of protems and peptides has created

challenging

new problems concerning means for the effective delivery of the molecules to the

patient In general these molecules aie difficult to stabilize and often undei go a

πety of physical and chemical transfoπnations including precipitation, aggregation

and oxidation Further, they are poorh absorbed after oral administration Most

protems now being used or under de\ elopment are given parenterallv in order to

insure rapid onset of action, with the mam routes of delivery being intravenous,

intramuscular, or subcutaneous Intravenous administration lesults m the fastest.

intramuscular injection is next, and subcutaneous injection exhibits the slowest on¬

set of action While other nomnvasive methods of delivery, such as iontophoresis

and nasal or buccal administration have been investigated, they have not been

widely adopted

A major advantage of infusion therapy is the opportunity to avoid repeated

injections and to achieve a constant or controlled rate of delivery of the medicinal

agents. Accordingly, many types of sophisticated electronic infusion devices have

been suggested to achieve complex patterns of dosing which are customized to the

patient's need and do not require repeated injections in order to maintain a constant

level of protems m the blood Another major advantage of infusion therapy over

repeated needle injections resides in the fact that such therapy is less time con¬

suming and considerably less costh because the care giver can administer a single

dose instead of multiple injections given over a peπod of time

The primary disadvantage of infusion therapy is its limiting effect on the pa¬

tient's lifestyle This is largely due to the physical size of the prior art

and the many precautions associated with parenteral therapy. Additionally, many of

die prior art portable electromechanical devices are generally quite fragile and

must be carefully handled to avoid breakage and preclude operational malfunction.

Experience has shown that while a patient will tolerate restrictions on an active

lifestyle for short periods of time, long-term use of the prior art devices have

tended to create significant patient intolerance. In addition to the precautions asso¬

ciated with using the prior art devices, there are numerous logistical issues of bat¬

tery changing and frequent replacement and the dedicated pump accessories.

These logistical issues substantially contribute to the overall cost and complexity

of prior art infusion therapy.

The unique combination of features in the apparatus of the present invention

make it superior to virtually all currently existing competitive systems. For exam¬

ple, although stationary electronic syringe pumps offer an excellent flow rate accu¬

racy of 3-10%, they are expensive, high maintenance devices and do not allow pa¬

tient mobility. Recently, portable, miniaturized versions of these syringe pumps

have been developed which allow greater freedom; however, they are often fragile,

non-waterproof and complicated to use, requiring battery and accessory changes.

Also problematic is the fact that both of the latter two types of devices often re¬

quire drugs to be diluted for parenteral administration, which may lead to unneces¬

sary patient overhydration. In addition to syringe systems, depot delivery (via sub- cutaneous or intramuscular implants) has been developed for continuous infusion;

however, its high cost, asiveness and inability to

drug stabilit) makes it

an unattractive alternative to potential users

Because the present application discloses mrprovements to the apparatus de¬

scribed in the United States Serial No. 08/768,663, this co-pendmg application is

also hereby incorporated by reference in its entirely as though fully set forth

herein.

The elastomeric film materials used in the apparatus of the present inven¬

tion, as well as various alternate constructions are descπbed in detail m U.S. Patent

No. 5,205,820 issued to one of the present inventors Therefore, U.S. Patent No.

5,205,820 is also incorporated by reference in its entirety as though fully set forth

herein.

As will be better appreciated from the discussion which follows, the appa¬

ratus of d e invention can be used with minimal professional assistance m an alter¬

nate health care environment, such as the home By way of example, the com¬

pletely mechanical devices of the invention can be comfortably and conveniently

removably affixed to the patient's body and can be used for continuous infusion of

various medicinal agents over substantial periods of time

Because the present invention comprises an improvement over the embodi¬

ments of the invention described in Serial No 08/768,663, this latter application is incorporated herein by reference as though fully set for the herein. While the in¬

ventions described in Serial No. 08/768,663 comprise fluid delivery devices having

a fluid reservoir and an indicator assembly for indicating fluid flow through the

apparatus d ey do not include the highly novel, adjustable fluid flow rate mecha¬

nism of the present invention which enables the fluid contained within the reser¬

voir of the device to be precisely dispensed at various selected rates. As will be

better understood from the description which follows, die novel adjustable fluid

flow rate control mechanism of the present invention also includes novel locking

means for preventing unauthorized adjustment of the rate control mechanism. This

novel locking means is operable only by a physician or health care worker who is

in possession of a physician operating key. Accordingly, once a particular flow

rate is selected, the patient cannot unilaterally change the flow rate.

Summary of the Invention

It is an object of the present invention to provide an apparatus for expelling

fluids at a precisely controlled rate which is of a compact laminate construction.

More particularly, it is an object of the invention to provide such an apparatus

which can be used for the precise infusion of pharmaceutical agents, including

proteins and peptides into an ambulatory patient at controlled rates over extended

periods of time. It is an object of the present invention to provide an apparatus of the

aforementioned character which is highly reliable and easy-to-use by lay persons in

a non-hospital environment.

Another object of the invention is to provide an apparatus which can be fac¬

tory prefilled with a wide variety of medicaments or one which can readily be

filled in the field shortly prior to use.

A further object of the invention is to provide a low profile, fluid delivery

device of laminate construction which can be manufactured inexpensively in large

volume by automated machinery.

Another object of the invention is to provide a device of the aforemen¬

tioned character which includes novel fluid flow control means that are disposed

inteπnediate die fluid reservoir outlet and die outlet port of the device for precisely

controlling the flow of fluid flow from the outlet port toward the patient.

Another object of the invention is to provide an apparatus of the aforemen¬

tioned character in which the fluid flow control means comprises rate control

means that includes a rotatable flow restrictor support disk that can be rotated by

the treating physician to selectively position the flow restrictor between the fluid

reservoir and the device outlet port so as to precisely control the rate of flow of

beneficial agents from the fluid reservoir toward the patient. Another object of the present invention is to provide a flow rate control

means of die type described in the preceding paragraph in which the flow restric-

tors comprise porous frits of varying porosity .

Anodier object of the present invention is to provide a flow rate control

means in which the flow restrictors comprise a laser drilled thin film.

Anodier object of the invention is to provide an apparatus as described in the

preceding paragraphs which includes locking means for locking the variable flow

rate control means in a preset position so that the rate control can be set only by the

treating physician or an authorized health care worker having an operating key.

Another object of the invention is to provide an apparatus of the aforemen¬

tioned character in which the stored energy source is of a novel construction that

can be precisely tailored to continuously deliver fluid from the device to the patient

Another object of the invention is to provide fill means for use in controlla-

bly filling the fluid reservoir of the apparatus.

Another object of the invention is to provide a novel vial assembly for use

with the fluid dispenser subassembly of the apparatus which is easy to use, is inex¬

pensive to manufacture, and one which maintains the vial in an aseptic condition

until time of use. Odier objects of the invention are set forth in U. S. Patent No. 5,205,820

which is incorporated herein and still further objects will become more apparent

from the discussion which follows.

By way of summary, the fluid delivery apparatus of the present form of the

invention comprises two cooperating components, namely a fluid dispenser and a

novel, adjustable fluid flow control assembly for selecting the desired fluid flow

rate to die patient. The fluid dispenser, which readily lends itself to automated

manufacture, is generally similar to that described in copending Serial No.

09165,713, which application is incorporated herein by reference and includes a

base and a stored energy means comprising at least one distendable elastomeric

membrane which cooperates with the base to foπn a fluid reservoir, hi at least

one fonn of the invention, the fluid dispenser includes a novel infusion means

tiiat can be conveniently stored in a forward compartment of the device housing.

Brief Description of the Drawings

Figure 1 is a generally perspective bottom view of one fonn of the infusion

device of the present invention.

Figure 2 is a generally perspective top view of the infusion device shown in

figure 1.

Figure 3 is a top plan view of the apparatus shown in figure 1. Figure 4 is a front elevational view of the apparatus of the invention.

Figure 5 is a cross-sectional view taken along lines 5-5 of figure 4.

Figure 6 is a cross-sectional view taken along lines 6-6 of figure 5

Figure 7 is a cross-sectional view taken along lines 7-7 of figure 5.

Figure 8 is an enlarged, cross-sectional view taken along lines 8-8 of figure

5.

Figure 9 is a cross-sectional view taken along lines 9-9 of figure 8.

Figure 10 is an enlarged, cross-sectional view taken along lines 10-10 of fig¬

ure 7.

Figure 11 is an enlarged, cross-sectional view taken along lines 11-11 of fig¬

ure 5.

Figure 12 is an enlarged cross-sectional view taken along lines 12-12 of fig¬

ure 5.

Figure 13 is a cross-sectional view taken along lines 13-13 of figure 12.

Figure 14 is a cross-sectional view taken along lines 14-14 of figure 5.

Figure 15 is a front-elevational view of one form of the control member of

the adjustable rate control means of the invention.

Figure 16 is a cross-sectional view taken along lines 16-16 of figure 15. Figure 17 is a generally perspective exploded view of the apparatus of the

present foπn of the invention showing the appearance and interrelationship among

the various component parts of the apparatus.

Figure 18 is a generally perspective, exploded view similar to figure 17 and

showing the fluid flow paths through the apparatus

Figure 19 is a cross-sectional view illustratmg the manner of assembly of the

fill vial of the apparatus with the housing.

Figure 20 is a generally perspective view of an alternate form of the infu¬

sion device of the present invention.

Figure 21 is a generally perspective exploded view of the infusion device

shown in figure 20.

Figure 22 is a cross-sectional view taken along the horizontal center line of

the apparatus shown in figure 20 (see lines 22-22 of figure 28)

Figure 23 is a front view of the apparatus shown in figure 20

Figure 24 is a rear view of the apparatus shown in figure 20

Figure 25 is a cross-sectional view taken along lines 25-25 of figure 22

Figure 26 is a left side view of the apparatus shown in figure 1

Figure 27 is a cross-sectional view taken along lines 27-27 of figure 22

Figure 28 is a cross-sectional view taken along lines 28-28 of fιgure22

Figure 29 is a cross-sectional view taken along lines 29-29 of figure 22 Figure 30 is a cross-sectional view taken along lines 30-30 of figure 29.

Figure 31 is a cross-sectional view taken along lines 31-3 1 of figure 22.

Figure 32 is a cross-sectional view similar to figure 31 but showing the

locking pin of the device moved into a locking position.

Figure 33 is a cross-sectional view taken along lines 33-33 of figure 22.

Figure 34 is a generally perspective exploded view similar to figure 21 and

showing the fluid flow paths through the device.

Figure 35 is a generally perspective bottom view of still another form of the

apparatus of the present invention which is of a somewhat different configuration.

Figure 36 is an enlarged bottom view of the device shown in figure 35.

Figure 37 is a generally perspective, exploded bottom view of the fluid dis¬

penser shown in Figure 35.

Figure 38 is a side-elevational, cross-sectional view of the apparatus.

Figure 39 is an enlarged, cross-sectional view of the area designated in Fig¬

ure 38 by the numeral 39.

Figure 40 is a cross-sectional exploded view of the portion of the device

shown in figure 39.

Figure 41 is a cross-sectional view of the control shaft of the device.

Figure 42 is a view taken along lines 42-42 of figure 41. Figure 43 is a top plan view of the rate control selector wheel of the device

of this latest form of the invention.

Figure 44 is a top plan view of the indicator disk of the device which carries

flow rate indicia.

Figure 45 is a cross-sectional view taken along lines 45-45 of figure 44.

Figure 46 is a generally perspective view of yet another fonn of the fluid

dispenser of the invention.

Figure 47 is an enlarged bottom plan view of the device shown in figure 46.

Figure 48 is a generally perspective, exploded bottom view of the fluid dis¬

penser shown in figure 46.

Figure 49 is a side-elevational, cross-sectional view of the dispenser partly

broken away to show internal construction.

Figure 50 is an enlarged, cross-sectional view of the area designated in fig¬

ure 49 by the numeral 50.

Figure 51 is a top plan view of the rate control film of the device shown in

figure 50.

Figure 52 is a top plan view of the rate control housing of the device.

Figure 53 is a cross-sectional view taken along lines 53-53 of figure 52.

Figure 54 is a generally perspective view of still another form of the fluid

dispenser of the invention. Figure 55 is an enlarged bottom plan view of the device shown in figure 54.

Figure 56 is a side-elevational, cross-sectional view of the dispenser.

Figure 57 is a view taken along lines 57-57 of figure 56.

Figure 58 is a cross-sectional view of a portion of the control assembly of

d e device shown in figure 57.

Figure 59 is a view taken along lines 59-59 of figure 58.

Figure 60 is an enlarged, generally perspective, exploded view of the flow

control assembly of this latest form of the invention.

Discussion of the Invention

Referring to the drawings and particularly to figures 1 d rough 7, one form

of die apparatus of the invention for controlled delivery of medicinal fluid flow to

a patient is there shown. The apparatus here comprises four major components

which are generally designated in figure 1 as a hollow housing 30, a fill assembly

32, an adjustable flow rate mechanism 34 and an indicator assembly 36 for indi¬

cating fluid flow to the patient. Housing 30 of the apparatus is similar in some re¬

spects to diat described in U.S. Patent No. 5,721 ,382 in that it includes a base as¬

sembl^e 42 a stored enεr^m' means which cooⁿerates with the base assεmbl to

fonn a fluid reservoir and an indicator assembly which provides a visual indication

of fluid flow through the device. Because of the pertinence of U.S. Patent No.

5,721 ,382, this patent is incorporated by reference as though fully set forth herein. Also generally pertinent to a complete understanding of the present invention is the

apparatus disclosed in co-pending U S application, Serial No 08768,663 filed on

December 18, 1996. This application is also incorporated by reference as though

fully set forth herein.

Considering first the hollow housing assembly 30, tliis assembly is provided

widi a uniquely configured receiving chamber 40 which is foπned between the

base assembly 42 and an interconnected cover component 44 (figures 4 and 17).

Base assembly 42 and cover component 44, when interconnected, cooperate to de¬

fine hollow housing assembly 30. hi a manner presently to be described, chamber

40 is adapted to telescopically receive the fill assembly of the invention to pennit

controlled filling of the reservoir of the device with a fluid to be dispensed to the

patient.

Turning particularly to figures 17 and 19, the fill assembly portion of the ap¬

paratus can be seen to comprise a container subassembly 48 and an adapter subas¬

sembly 50, the character of which will presently be described. Container assembly

48 includes a body portion 48a having a fluid chamber 48b for containing an in-

jectable fluid "F". Chamber 48b is provided with first and second open ends, one

of which is sealably closed by closure means here provided in the form of a pierce-

able septum assembly 52. Septum assembly 52 is held securely in position by a

clamping ring 52a (figure 19) As best seen in figure 19, a plunger 56 is telescopi- cally movable within chamber 48b of container assembly 48 between first and sec¬

ond locations. As is also shown in figure 19 subassembly 50 comprises a hollow

housing 50b having a first open end 50c and a second closed end 50d. The adapter

assembly 50 is telescopically receivable within an elongated, generally annular

passageway 60 formed in device housing 30 in the manner shown in figure 19 so

tiiat the adapter assembly can be moved from a first extended position into a sec¬

ond vial encapsulation position. The adapter subassembly also includes pusher

means shown here as an elongated pusher rod 62 which functions to move plunger

56 within the fluid chamber 48b of the container subassembly. Pusher rod 62 has a

first end 62a which is interconnected with closure wall 50d and an opposite end

62b which engages plunger 56 and causes telescopic movement of the plunger

forwardly within chamber 48b. Housing 50b includes a plurality of spaced-apart

teetii 50d which are lockably engaged by a locking tab 51a provided on a locking

clip 51 (figure 17) which is earned by base 42. Those components, which com¬

prise the adapter locking means, cooperate to lock the adapter against removal after

it has been fully inserted into the housing.

As best seen in figure 19, provided within housing 30 is an elongated, gener¬

ally cylindrically shaped wall 63 which is concentric with the outer housing wall

which defines receiving chamber 40. Wall 63 is radially spaced from the outer

wall 31 of the housing so as to define the longitudinally extending annular space 60 (figures 6 and 19). With this constniction, during the mating of the reservoir fill

assembly with the base assembly, the outer wall of the housing 50 is closely re¬

ceived within space 60 as the adapter subassembly is urged inwardly or forwardly

of the device housing 30 . At the same time that hollow housing 50 moves for¬

wardly of annular space 60, the container assembly telescopically moves inwardly

so as to move septum 52d of septum assembly 52 into piercing engagement with a

hollow cannula 67 which is connected to a base wall 70 so that it extends inwardly

into chamber 40 (see figure 5).

As plunger 56 of the container assembly is moved forwardly of container

48a by pusher rod 62, the fluid contained within the container will flow under pres¬

sure into a passageway 72 via a hollow cannula 67 and via a valve means, shown

here as an umbrella type check valve 74. Check valve 74 is disposed within a cav¬

ity 76 fonned in housing 30 in the manner shown in figure 5. Valve 74 is con¬

structed from an appropriate elastomer and has a resiliently defonnable skirt por¬

tion 74a which will deform inwardly within cavity 76 to permit fluid flow toward

the reservoir of the device, but will block reverse flow. From passageway 72, the

fluid will flow into a passageway 78, then into passageway 80 formed in a mani¬

fold 81, and finally into reservoir 82 via a passageway 84. As a fluid flows into

reservoir 82 it will cause the stored energy means or membrane 86 (figure 7) to

extend outwardly from an ullage substrate 88a formed in a base platform 88 which comprises a part of the base assembh 42 (figure 7) As best seen in figure 7, ul¬

lage substrate 88a is specially configured to receive a membiane clamping ring 89

which mates with ullage substrate 88a in a manner shown m figure 7 to clamp

membrane 86 about its periphery 86a With this construction distendable mem¬

brane is securely clamped in position w ith cover 44 overlaying ullage substrate 88a

and membrane 86 in a manner to sealably enclose the assembly withm the hollow

housing portion of the device

After the reservoir has been filled and as membrane 86 moves toward sub¬

strate 88a during the fluid dispensing step, fluid withm reservoir 82 will be uni¬

formly and controllably forced outwardly through a passageway 84 and then on

toward the important flow control means of the invention

As illustrated m figures 3 and 5, the embodiment of this latest form of the

invention also includes a uniquely designed fluid recovery means mounted within

manifold 81 As indicated in figures 5 and 17. manifold 81 is connected to ullage

substrate 88a and is in communication with reservoir 82 so that fluid can be recov¬

ered as may be desired from reservoir 82 This novel recovery means here com¬

prises a recovery septum assembly 94 which is mounted withm a cavity 95 formed

m manifold 81 Septum assembly 94 includes a septum retainer ring 96a (figure

17) and a pierceable elastomeπc septum 96 of generally conventional design

Septum 96 includes an internal chambei 96b which is in communication with a fluid passageway 97 which, in turn, communicates with reservoir 82 via passage¬

ways 78, 80 and 84. Septum 96 is pierceable by the cannula of a conventional sy¬

ringe so tiiat, as desired, fluid can be readily recovered from reservoir 82 using a

conventional syringe.

Turning particularly to figures 13 and 17, the novel delivery line intercon¬

nection and release means of the invention is there illustrated. This means func¬

tions to releasably interconnect the delivery assembly, which is of the character

shown in figures 1 and 17 to housing 30. This novel interconnection and release

means here comprises a push button subassembly 100, which includes a head por¬

tion 100a and a pair of yieldably defonnable legs 102 (figure 13). A part of head

portion 100a extends tlirough an aperture 104 foπned in closure component 110 in

d e manner shown in figure 13 so that the defonnable legs 102 engage the ramp

sides 106a and 106b of a ramp unit 106 (figure 17). Ramp unit 106 is connected to

the base portion of a closure component 1 10 which closes the back end of housing

30. Each of the legs 102 of the push button subassembly lockably engages a

shoulder 112 provided on the delivery fitting 1 14 (figure 17) when the push button

subassembly is in an upward, at-rest position. It is apparent that a downward force

exerted on head portion 100a will cause legs 102 to move downwardly along

rampsides 106a and 106b causing legs 102 to spread apart a sufficient distance to

clear shoulder 112 so as to permit withdrawal of delivery fitting 1 14. When the delivery line is connected to the housing in the manner described, fluid can flow

from reservoir 82 outwardly of the device via a novel flow rate control means, the

character of which will next be described.

The flow rate control means is a very important feature of the apparatus of

die invention and functions to adjustably control the rate of fluid flow from the

reservoir 82 of the apparatus to the device outlet passageway 118. This novel

means here comprises the previously mentioned adjustable rate control mechanism

34 which is carried by housing 30. As best seen in figures 6, 15, and 16, mecha¬

nism 34 includes a central body portion 122 which is disposed internally of a

knurled control knob 124. Knob 124 is rotatably supported by members 126 and

128 which are mounted internally of housing 30 (figure 17). O-rings carried by

members 126 and 128 sealably engage control knob 124 and prevent fluid leakage

among the various cooperating components.

As best seen in figures 15 and 16. central body portion 122 caπies a plurality

of circumferentially spaced apart flow restrictors. By rotating knob 124, each of

the flow restrictors can be selectively moved into index with the flow passageways

which carry the fluid from reservoir 82 to the outlet of the device. In the embodi¬

ment of the invention shown in the drawings, the flow restrictors are provided in

the form of rate control frits 130 (see figures 15 and 16), which are secured in

place within apertures 122a formed in body 122 by a moldable elastomer 133 (see figure 16) With the construction shown, by rotating knob 124 relative to housing

30, each of the rate control frits 130 can be moved sequentially into alignment with

a fluid passageway 136 which extends tlirough members 126 and 128 (figures 17

and 18). Because each of the frits 130 is of a different, preselected porosity, it is

apparent that the rate of fluid flowing outwardly of the device through outlet pas¬

sageway 118 can be precisely controlled by positioning a particular frit in the flow

padi.

An important feature of the invention is the rate control lock-out means

which locks knob 124 against rotation. This lock-out means here comprises a

locking member 135 which is mounted on an elongated push rod 137 that is carried

by base 42 for movement between a first extended locking position and an mward

position. Extending from locking member 135 is a locking tab 135a which is mov¬

able into and out of locking engagement with channels 124a provided on knob 124

by movement of rod 137 between its first and second positions A rod biasing

means, here provided as a coil spring 139 which is earned withm the device hous¬

ing functions to continuously bias push rod 137 toward its second extended knob

engaging locked position As shown m figure 17, rod 137 can be locked m the

extended locked position by a lock means here provided as a generally cylindrical

shaped rotatable member 141 Member 141 has a stem portion 141 a which can be

rotated into and out of locking engagement with a notch 13~b formed in rod 137 The head portion 141b of member 141 has spaced apart spanner holes which re¬

ceive spanner pins 141c provided on the physician key 14 I d which is of the char¬

acter shown in figure 17 Disabling means for disabling the device is here pro¬

vided in the fonn of a disabling button 138 (figures 14 and 17) which is carried by

base 42. Button 138 can be pushed into a cavity 135a in member 135 so as to pre¬

vent its movement and thereby disable the device

Another unique feature of the apparatus of the invention is a novel flow in¬

dicator means which functions to distinguish among three conditions of operation

of the device, namely normal fluid flow, blockage or occlusion, and reservoir

empty.

Turning particularly to figure 17, this novel flow indicator means here com¬

prises an indicator base or platfonn 140 and a boot clamping plate 142. Addition¬

ally, the indicator means comprises a support or lens plate 144 Platform 140,

clamping plate 142 and support plate 144 are all enclosed withm housing 30 to in

the manner indicated in figure 1 When the components are positioned within

housing 30, plate 144 is viewable tlirough an aperture 145 provided m housing 30

(see also figures 5 and 7)

Disposed between lens plate 144 and platform 140 are first and second indi¬

cia-carrying means shown here as a pair of closely adjacent, thin films 148 and

150 Films 148 and 150, are m intimate contact and are preferably constructed from a substantially transparent, flexible polymer material such as Mylar It is to

be understood that the mdicia-carry mg means need not be thm films, but rather can

be any type of surface presenting member upon which indicia can be provided

The downstream surface of the inferior or first film 148 is printed with three inte¬

grated symbols (see figures 4.6, and 8 of incorporated by reference Patent No

5,721,382, which may comprise, by way of example, a blue circle, a green arrow,

and a red cross, each consisting of diagonal strips of color printed in an alternating

pattern (blue, green, red, blue, green, red. and so on) The second film 150 serves

as a "mask" over film 148 and is printed with a pattern of diagonal alternating clear

and opaque strips that occur m approximately a 1 2 ratio The printed ratio of the

"mask" allows only one colored symbol to appear at a time when viewed tlirough

viewing lens plate 144 The inferior and superior films aie provided at their oppo¬

site ends with apertures 152 which receive retention pms 154 provided on platform

140 (figure 17) which permit attachment of the film to platform 140 m a manner

such that the non-patterned portions of each film covers boot openings 140a and

140b provided proximate each end of platform 140 with the patterned portions of

both the superior and inferior films being maintained in index With this construc¬

tion, each thm film is able to move m response to pressure exerted thereon by the

actuating means of the invention, the character of which will presently be de¬

scribed, in opposing directions parallel to the film plane with its range of motion limited to one axis in the film plane. As the films move, the visible symbol pattern

will, of course, change due to the transverse displacement of the patterns imprinted

d ereon.

As will be discussed in greater detail hereinafter and as is apparent from a

study of figures 17 and 18, the central portions of both the first and second elasto¬

meric actuator elements or boots 158 and 160, which here comprise the actuator

means of the invention, will be deflected outwardly in a direction toward plate 144

when the device is filled and primed, but not in a state of delivery or when there is

a build up of fluid pressure during delivery that is caused by blockage of the deliv¬

ery line downstream from boot 158. While boot 158 can be deflected by noπnal

line pressure, boot 160 is deflected only by pressure buildup resulting from die

downstream blockage (see figure 18). When both elastomeric boots 158 and 160

are deflected outwardly, both the superior and inferior films are displaced trans¬

versely to a second position revealing a second symbol, as for example, an X as

viewed tlirough the viewing aperture of the support plate (see also figures 35 and

36 of Patent No. 5,721,382 which is incorporated herein by reference).

A third alignment of symbol patterns as shown in figure 32 of patent No.

5,721,382 is visible when the device is in an unfilled state or when the delivery line

is open, the reservoir is empty and fluid delivery of the patient has been completed.

In this case, there is no fluid pressure in the line on either the upstream or the downstream side of the flow control means and thus both the first and second boots

are in a non-deflected position. In this condition, the inferior and superior films

are not transversely displaced and thus exhibit a third combination of patterns re¬

sulting in a third symbol as, for example, a circle being visible tlirough the viewing

aperture of the support plate. Boots 158 and 160 can be precisely tailored to de¬

flect under various pressures thereby permitting great apparatus versatility.

During the fluid dispensing step, when fluid is forced tlirough reservoir out¬

let 163 by the stored energy means, the fluid will flow into a passageway 165

formed in a first base connector element 168 which has a connector head 168a that

fits into a first socket 170 foπned in base platfonn 42a. Next, the fluid will flow

through an aperture 173 formed in plate 142 and finally into a chamber fonned in

d e distendable, elastomeric first boot 158 of the flow indicator means of the in¬

vention. Boot 158 includes a yieldably distendable fluid flow blocking body por¬

tion 158a which is circumscribed by a marginal portion 158b. Marginal portion

158b is clamped between plate 142 and platform 140 so that the boot extends

through opening 140a formed in platform 140. It is to be understood that, when

d e fluid flowing from reservoir 82 in the direction of the arrow 175 of figure 18

impinges upon boot 158, the central portion of the boot will be deflected outwardly

into pressural engagement with indicator film 148. Fluid flowing from reservoir 82 will also flow in the direction of arrow 177

(figure 18) into a stub passageway 126a fonned in member 126 and then through

aperture 136 foπned m member 126 After flowing through aperture 136, the fluid

will flow tlirough the flow restrictor that is aligned with aperture 136. (This flow

restrictor is identified m figure 18 by the numeral 130a Next, the fluid will flow

into through an aperture 136 fonned m a knob support platform 182 which is con¬

nected to base platform 42a The fluid will then be diverted m the direction of ar¬

row 185 of figure 18 into a passageway 188 formed m plate 142.

Next, the fluid will flow from passageway 188 into a chamber 160a formed

in elastomeric, distendable boot 160 which also fonns a part of the indicator means

of the invention. The periphery 160b of indicator boot 160, which is of identical

construction to boot 158, is clamped within opening 140b formed m platform 140.

After impinging on boot 160, the fluid will next flow back toward plate 142 in the

direction of arrow 189, tlirough an orifice 192 formed therein and into a second

base connector element 194 which has a base comiector head 194a that fits into a

socket 196 formed m base platform 42a From connector element 194, the fluid

will flow m the direction of arrow 197 toward the outlet port 118 of the device

(figure 18).

It is to be observed that fluid flowing from reservoir 82 into passageway

196, and then on toward boot 160 is under a lowei pressure than fluid flowing to- ward boot 158. This is because the pressure of the fluid flowing toward boot 160

has been reduced as a result of the fluid flowing tlirough the adjustable rate control

means of the invention. As is more fully discussed in incorporated by reference

Patent No. 5,721,382, this result enables a detennination of the various fluid flow

operating conditions of the device namely normal fluid flow, fluid flow blockage

or occlusion, and reservoir empty.

In addition to boots 158 and 160 the flow indicator means also comprises the

earlier identified lens 144, which along with platform 140 and support plate 142

are enclosed within housing 30. As best seen in figure 2, the viewing lens 144 is

viewable through an opening 145 provided in the forward wall.

In using the apparatus of the invention and after the reservoir had been filled

using the fill means, the flow rate control means is set to the desired rate of fluid

flow. This is done by rotating locking member 141 using a spanner type physi¬

cian's key. When tab 141a is rotated out of locking engagement with notch 137b,

push rod 137 can be pushed forwardly moving the extremity 135b of tab 135a out

of engagement with one of the finger engaging channels 124a formed in knob 124

so as to pennit rotation of the knob. After the knob has been rotated by the care

giver to bring the appropriate rate control frit 130 into index with the fluid flow

passageway, the push rod can be released so that spring 139 will urge the locking

tab once more into locking engagement with knob 124. By then rotating member 141 to its locked position and removing the spanner type physician's key from

head portion 141b, no further adjustment can be made to the rate control means.

Turning now to fi ures 20 tiirough 34, an alternate form of the apparatus of

die invention for controlled delivery of medicinal fluid flow to a patient is there

shown and generally designated by the numeral 200. The apparatus is similar in

many respects to that shown in figures 1 tlirough 19 and like numerals are used to

identify like components. The apparatus here comprises five major components

which include a hollow housing, a fill assembly, an adjustable flow rate mecha¬

nism and an indicator assembly for indicating fluid flow to the patient. Housing

202 of the apparatus is quite similar to that shown in figures 1 tlirough 19 and in¬

cludes a base assembly 204, a stored energy means which cooperates with the base

assembly to foπn a fluid reservoir and an indicator assembly which provides a vis¬

ual indication of fluid flow through the device. The device housing also carries the

important dosing means, the character of which will presently be discussed.

Considering first the hollow housing assembly 202, this assembly is here

provided with a uniquely configured receiving chamber 206 which is formed be¬

tween the base assembly 204 and an interconnected cover component 208 (figures

20 and 21). As before, base assembly 204 and cover component 208 when inter¬

connected, cooperate to define the hollow housing assembly 202. In a manner

presently to be described, chamber 206 is adapted to controllably receive the fill assembly of the invention to pennit controlled filling of the reservoir of the device

and the controlled dispensing of the medicament to the patient

Turning particularly to figures 21 and 22 the fill assembly portion of the ap¬

paratus can be seen to comprise a container subassembly 48, which is of identical

construction to that previously described, and an adapter subassembly 210, which

is of a slightly different configuration As before, a plunger 56 is telescopically

movable withm chamber 48b of container assembly 48 between first and second

locations As best seen m figure 22 adapter assembly 210 comprises a hollow

housing 210a having a first open end 210b and a second closed end 210c The

adapter assembly 210 is telescopically receivable withm an elongated, generally

annular passageway 214 formed m device housing 202 m the manner best seen in

figure 22 so that the adapter assembly can be moved from a first extended position

shown in figures 20 and 22 into a second fluid dispensing position As was the

case with adapter subassembly 50. adapter assembly 210 also includes pusher

means shown here as an elongated pusher rod 216 which functions to move

plunger 56 within the fluid chamber 48 of the container subassembly upon opera¬

tion of the dose control means of the invention

As best seen m figure 22. provided withm device housing 202 is an elon¬

gated, generally cylmdπcally shaped w all 220 which is concentric w ith the outer

device housing wall which defines receiving chambei 206 Wall 220 is radiallv spaced from the outer wall 203 of the housing so as to define the previously men¬

tioned longitudinally extending annular space 214 see also figure 25). With this

construction, during the mating of the reservoir fill assembly with the base assem¬

bly, the outer wall of adapter assembly 210 is closely received within space 214 as

d e adapter subassembly is urged inwardly or forwardly of the device housing by

means of the dose control means. When the adapter assembly is originally mated

with the device housing in the manner shown in figure 22, the container assembly

will be moved telescopically inwardly to move septum 52a of septum assembly 52

into piercing engagement with a hollow cannula 222 which extends inwardly into

chamber 206 (see figure 21).

Once the fluid flow path between the hollow cannula 222 and the fluid res¬

ervoir 224 of the apparatus is thus created via a passageway 226 (figure 22), an

inward movement of the adapter subassembly can be accomplished using the novel

dose control means of the invention As the operating mechanism of the dose con¬

trol means controllably moves the adapter subassembly inwardly, pusher rod 216

will move plunger 56 forwardly of chamber 48b. As plunger 56 is moved for¬

wardly, fluid contained within vial chamber 48b, will flow tlirough hollow cannula

222, past check valve 57, into passageway 226 and finally into fluid reservoir 224

(figure 25) In certain instances, reserv oir 224 may be pre filled with a saline solu- tion or the like with which the fluid contained in vial 48 will be controllably inter¬

mixed as the adapter assembly is moved inwardly.

Considering now the previously mentioned dose control means of the inven¬

tion, this important means here comprises a control knob assembly 230 which in¬

cludes a collar portion 230a. Assembly 230 is rotatably mounted within device

housing 202 so ti at a portion of the knob extends tlirough an opening 233 foπned

in cover 208 (figures 20 and 21 ). More particularly, control knob assembly 230 is

rotatably carried by a generally cross-shaped knob support member 236 which is

connected to a support platform 239. The details of construction of knob assembly

230 and the drive mechanism associated therewith for advancing adapter assembly

210 into housing 202 are illustrated in figures 21, 22, and 27. As indicated in fig¬

ure 27, control knob 230 is provided with gear teeth 230b which mate with teeth

238a fonned on an idler gear 238 which is rotatably carried within device housing

202 in the manner shown in figure 30. Idler gear teeth 238a, m turn, mesh with

teetii 240a fonned on the drive gear 240 which is rotatably supported by a shaft

242 mounted within device housing 202. Drive gear 240 engages longitudinally

spaced apart teetii 244 which are formed on adapter housing 210a (figure 21).

With this construction, as knob 230 is rotated by rotational forces exerted thereon,

adapter housing 210a will be caused to controllably move inwardly of annular

space 214 causing pusher rod 216 to move plunger 56 inwardly of vial assembly 48. In this way precise incremental doses of the medicament contained within vial

48 can be controllably introduced into reservoir 224. Indicia viewable tlirough a

window 249 formed in cover 208 indicate the volume of the dose being dispensed

(figure 20).

Once the reservoir has been filled and the adapter assembly has been appro¬

priately mated with device housing 202, the apparatus will remain in this readied

condition until the outlet passageway of the device is opened. Once the outlet pas¬

sageway has been opened, the stored energy means or membrane 250 will tend to

return to a less distended condition causing fluid to flow outwardly of the appara¬

tus via a passageway 252 formed in base assembly 204, tlirough the novel rate

control means of the invention and finally outwardly of the device via an outlet

portion 254 (figure 34). In a manner presently to be described, a comiector 256

and delivery line 258 are connected to the outlet port 254.

As best seen in figure 28, base platform 204a, which includes an ullage pro¬

tuberance 260, is specially configured to receive a membrane clamping ring 262

which functions to securely clamp membrane 250 about its periphery 250a. With

this construction, distendable membrane 250 is securely clamped in position with

cover 208 overlaying membrane 250 in the manner shown in figures 25 and 28.

Turning next to figures 20, 21, and 33, the novel delivery line interconnec¬

tion and release means of the invention is there illustrated. This means functions to releasably interconnect the delivery assembly, which here includes connector 256

and delivery line 258. This novel interconnection and release means here com¬

prises a push button subassembly 260, which includes a head portion 260a which

extends through an opening 261 fonned in cover 208. Connected to head portion

260a is a leg 264 which terminates in a tab 266 which is securely connected to

cover 208 (figure 33). Disposed between leg 264 and tab 266 is a yieldably de¬

fonnable segment 268 which functions as a living hinge so diat pushing upon head

260a will cause leg 264 to move out of locking engagement with a shoulder 256a

foπned on connector 256. When the push button subassembly is in an upward, at-

rest position, leg 264 locks against shoulder 256a preventing removal of connector

256 from the device housing. However, it is apparent that a downward force ex¬

erted on head portion 260a will cause legs 264 to move away from the connector

so as to pennit it to be disconnected from housing 202. When the delivery line is

connected to the housing in the manner described, fluid can flow from reservoir

224 outwardly of the device via the indicator means and via the novel flow rate

control means, the character of which will next be described.

The flow rate control means is also a very important feature of this latest

fonn of the invention and functions to adjustably control the rate of fluid flow from

the reservoir 224 of the apparatus to the device outlet passageway 254. This novel

rate control means is virtually identical in construction and operation to that de- scribed in connection with the first embodiment of the invention shown in figures 1

tlirough 19. As before, the rate control means comprises a mechanism 124 which

includes a central body portion 122 which is disposed internally of a knurled con¬

trol knob 124. Knob 124 is rotatably supported by members 126 and 128 which

are quite similar to the previously described members 126 and 128 and are

mounted internally of housing 202 (figures 17 and 34). A portion of knob 124 ex¬

tends tlirough an opening 267 foπned in cover 208 (figure 20)

As best seen in figures 31 and 32, central body portion 122 carries a plurality

d e flow restrictors can be selectively moved into index with the flow passageway

252 (figure 28) which carries the fluid from reservoir 224 to support member 126

of the device. In die mamier previously described, by rotating knob 124 relative to

housing 202, each of the rate control frits 130 can be moved sequentially into

alignment with fluid passageway 252 and with a passageway 126a (figures 28 and

34) which extends tlirough member 126. Because each of the frits 130 is of a dif¬

ferent, preselected porosity as indicated by indicia viewable tlirough a window 255

formed in cover 208, it is apparent that the rate of fluid flowing outwardly of the

device tlirough outlet passageway 254 can be precisely controlled by positioning a

particular frit in the flow path. Another unique feature of the apparatus of this latest form of the invention

which is shown in figures 21, 31, and 32 is a novel control knob locking means

which locks knobs 124 and 230 against rotation. This locking means here com¬

prises yieldable knob engagement arms 270 which engage knobs 124 and 230 and

prevent their rotation when a locking button 272 is pushed inwardly of housing 202

in die manner shown in figure 32. Anns 270 terminate in an end portion 270a

which ratchet out of engagement with the grooves 124a formed in knob when the

push button is in the retracted position shown in figure 31. However, when the

push button is pushed in, it will engage arm 270 to prevent its separation from

knob 124. Push button 272 is provided with spanner holes 272a (figure 26) which

accept spaced apart pins provided on a physician's locking key 14 Id (figure 17)

which can be used to lock the push button in the locked configuration shown in

figure 32. With this arrangement once the flow rate is set it cannot be changed by

anyone other than an authorized care giver having access to the locking key.

As in the earlier described embodiment, this latest embodiment also includes

novel indicator means which functions to distinguish among three conditions of

operation of the device, namely normal fluid flow, blockage or occlusion, and res¬

ervoir empty. Turning particularly to figures 21 and 34, this novel flow indicator

means is quite similar in construction and operation to the previously described

flow indicator means and includes an indicator base or platform 276 and a boot clamping plate 278. Additionally, the indicator means here comprises a support or

lens plate 280. Platform 276, clamping plate 278 and support plate 280 are all en¬

closed within housing 202 in the manner indicated in figure 21. When the compo¬

nents are positioned within housing 202, plate 280 is viewable tlirough an aperture

282 provided in housing 202 (figure 20).

Disposed between lens plate 280 and platform 276 are first and second indi¬

cia-carrying means shown here as a pair of closely adjacent, thin films 148 and 150

which are of identical construction and operation to those embodied in the first

form of die invention (see also figures 4,6, and 8 of incorporated by reference Pat¬

ent No. 5,721,382. The inferior and superior films are provided at their opposite

ends with apertures 152 which receive retention pins 276a provided on platfonn

276 (figure 34) which permit attachment of die film to platform 276 in a mamier

such that the non-patterned portions of each film covers boot openings 286 and 288

provided proximate each end of platform 276 with the patterned portions of both

d e superior and inferior films being maintained in index. With this construction,

each thin film is able to move in response to pressure exerted thereon by the actu¬

ating means of the invention which is of the character previously. As the films

move, the visible symbol pattern will, of course, change due to the transverse dis¬

placement of the patterns imprinted thereon. As before, boots 158 and 160, which here comprise the actuator means of

dns latest fonn of the invention, will be deflected outwardly m a direction toward

plate 280 when the device is filled and primed, but not m a state of delivery or

when there is a build up of fluid pressure during delivery that is caused by block¬

age of the delivery line downstream from boot 158 While boot 160 can be de¬

flected by nonnal line pressure, boot 158 is deflected only by pressure buildup re¬

sulting from the downstream blockage When both elastomeric boots 158 and 160

versely to a second position revealing a second symbol, as for example, an X as

36 of Patent No 5,721,382 which is incorporated herein by reference).

A third alignment of symbol patterns as shown in figure 32 of patent No

is open, die reservoir is empty and fluid delivery of the patient has been completed

In this case, there is no fluid pressure in the line on either the upstream or the

downstream side of the flow control means and thus both the first and second boots

are in a non-deflected position In this condition, the interior and superior films are

not transversely displaced and thus exhibit a third combination of patterns resulting

in a third symbol as, for example, a cncle being visible tlirough the viewing aper- ture of the support plate As before boots 158 and 160 can be precisely tailored to

deflect under various pressures thereby pennitting great apparatus versatility

During the fluid dispensing step, when fluid is forced tlirough the reservoir

outlet by the stored energy means, the fluid will flow into passageway 252. and

dien will be split into two flow paths 252a and 252b Flow path 252a extends

through a first orifice 126c formed m member 126 and then tlirough a central on-

fice 122a fonned in control member 122 Flow path 252b extends tlirough a sec¬

ond orifice 126a fonned m member 126 and then tlirough a selected frit 130 of the

rate control means. From the selected frit 130, the fluid will flow at a reduced

pressure into a chamber fonned m the distendable elastomeric first boot 158 m the

direction of the arrows 291 When the fluid flowing from reservoir 224 in the di¬

rection of the arrow 291 of figure 34 impinges upon boot 158, the central portion

of the boot will be deflected outwardly into pressural engagement with indicator

film 148. After impacting boot 158. the low pressure fluid will then flow back into

outlet passageway 294 (figure 22) and outwardly of outlet 254 at the predeter¬

mined rate of flow.

Fluid flowing from reservoir 224 along path 252a will flow tlirough orifice

126c foπned in member 126 and then tlirough a passageway fonned m hub-like

member 236 Next, fluid will flow in the direction of arrow s 295 into elastomeric, distendable boot 160 which also forms a part of the indicator means of this latest

form of the invention.

It is to be observed that fluid flowing from reservoir 224 along path 252a

and through central orifice 122a of member 122 will flow toward boot 160 under a

higher pressure than fluid flowing toward boot 158. This is because the pressure of

die fluid flowing toward boot 158 has been reduced as a result of the fluid flowing

through the adjustable rate control means of the invention. As is more fully dis¬

cussed in incorporated by reference Patent No. 5,721,382, this result enables a de¬

termination of the various fluid flow operating conditions of the device namely

normal fluid flow, fluid flow blockage or occlusion, and reservoir empty.

Turning next to figures 35 dirough 45, one form of the fluid dispenser as¬

sembly of the apparatus of the invention is diere shown and generally designated

by die niuneral 322. The fluid dispenser component of the apparatus is somewhat

similar in operation to that previously described herein, but is of a somewhat dif¬

ferent configuration. As best seen in figures 35 dirough 38, this latest embodiment

includes a housing assembly 324 having a base 326 and a stored energy source, or

distendable membrane 328 (figure 38) which is superimposed over base 326 and is

clamped thereto by a clamping ring 330. A cover 331 is provided for enclosing the

stored energy source and the capture ring. As indicated in figures 38 and 39, the

base 326 includes an ullage defining protuberance 326a and a membrane capture portion 326b Membrane capture or clamping πng 330 has a bottom opening 330a

which receives protuberance 326a of base 326 in the manner best seen in figure

38

Referring particularly to figures 37, 38. and 39, base 326 comprises, in ad¬

dition to the distendable member, engaging protuberance, or ullage 326a, con¬

nector means, the character of which will presently be descπbed, for connecting to

the base one form of the novel fluid flow control means of d e invention Base 326

also includes an upstanding tongue 326c which extends about the perimeter of the

base and is closely receivable with a groove 330b formed m the capture ring 330

(figure 38) When the base and d e membrane capture ring are assembled in the

manner shown in figure 38, d e periphery of distendable membrane 328 will be

securely clamped within groove 330b by tongue 326c. After die parts are d us

assembled, base 326 is bonded to capture πng 330 by any suitable means such as

sonic bonding which also functions to simultaneously trim membrane 328.

Also comprising a part of housing assembly 324 is filling means for filling

the fluid reservoir 332 of the fluid dispenser assembly, which reservoir is defined

by die upper surface of base 326 and die lower surface of distendable membrane

328. This filling means here comprises a fill assembly 334 which includes a fill

port 336 that is connected to base 326 and valve means for controlling fluid flow

toward rescrvoπ 332 Fin^'s valve means here comprises a conventional umbrella

o valve 338 that is disposed withm a chambei 339 fonned in base 326 (figure 39)

During the reservoir filling step, a closure cap 340 is fust removed and a

fill line having an appropriate luer connector is connected to fill port 336 This

done, fluid under pressure will flow into mlet passageway 342 of die fluid dis¬

pense! via an umbrella valve 338 and thence into a reservoir 332 As the fluid un¬

der pressure flows into the reservoir, it will cause membrane 328 to distend

outwardly from protuberance 326a in the maimer shown by the phantom lines in

figure 38 Check valve 338 will, of course, prevent fluid flow in a direction from

reservoir 332 toward fill port 336

As indicated m figure 35, infusion set storage means for storing the infusion

set or infusion means of the apparatus is provided proximate the forward end of the

housing of the dispenser This storage means here comprises a part of the cover

means of the invention winch includes the previously identified cover 331 The

cover means also includes a forward housing portion 344 (figure 35) which is in¬

terconnected with cover 331 and base 326 Housing portion 344 functions to close

the forward or delivery end of the dispenser component As best seen in figure

38, housing portion 344 includes a front face 346 that is provided with a plurality

of socket-like cavities that house the component parts of the infusion set of the in¬

vention, name'y an infusion line 348, a gas vent assembly 350, a line clamp 352

and an outlet luci connector 354 When forward housing portion 344 is mated w ώ base assembly 326, infusion line 348 will communicate with outlet passageway

332a of reservoir 332 via an outlet passageway 356 fonned in base 326 (figure 38).

In a manner presently to be described, passageway 356, in turn, communicates

with reservoir 332 via the novel fluid flow control means of the invention.

The novel fluid flow control means of the fonn of the invention shown in

figures 35 tlirough 45 comprises a novel flow control assembly 360 which includes

a rate control shaft 362 that is rotatably mounted within a cylindrical bore 364

fonned in base 326 (figure 40). As best seen in figures 39 and 42, shaft 362 is

provided with a plurality of circumferentially spaced, radial bores 366 within

which are mounted first, second, diird, fourth and fifth flow restrictors or porous

frits 368, 370, 372, 374 and 376 respectively. Connected to shaft 362 proximate its

outboard end is a rate control wheel 380. Wheel 380 includes an indexing notch

381 for appropriately indexing wheel 380 to shaft 362. Shaft 362 has a boss 381a

which fits into indexing notch 381 on wheel 380. With the construction shown, by

rotating control wheel 380 relative to base 326, each of the porous control frits can

be moved sequentially into alignment with outlet passageway 356. Because each

of the rate control frits is of a different, preselected porosity, it is apparent that the

rate of fluid flowing outwardly of the device throughout passageway 356 can be

precisely controlled by positioning a particular frit in the flow path between reser¬

voir 332 and outlet passageway 356. In certain instances, it may be beneficial to prefilter the fluid flowing toward the rate control frits by means of a filter 333 (fig¬

ure 38). O-rings 365 are provided in the manner shown in figures 38 and 39 to

prevent leakage past the cooperating components.

Located proximate rate control selector wheel 380 is a flow rate indicator

disk 382. Disk 382 is provided with indicia 384 viewable tlirough a viewing win¬

dow 380a foπned in wheel 380 which indicia indicate flow rate through the various

porous rate control frits mounted within shaft 362.

With the constniction described in the preceding paragraphs, once die fluid

reservoir is appropriately filled, d e desired rate of infusion to the patient can be set

by d e physician or other caretaker by rotating the control member 380 until the

desired flow rate appears tlirough window 380a. Once the flow rate is set, a

tiireaded locking member or screw 386, which is rotatable relative to base 326 in

the manner shown in figures 38 and 39, is rotated to secure control member 380

against further rotation. Locking member 386, which comprises a part of the

locking means of the invention is threadably connected to a control member en¬

gaging component 388. Component 388 includes a central body portion 388a

having a threaded aperture 388b and a pair of outwardly extending, arm-like protu¬

berances 388c. Connected to each protuberance 388c is a downwardly extending

stub shaft 388d. Each stub shaft is slidably receivable within a bore 390a foπned

in a screw housing 390 provided on base 326 (figure 37). A screw retainer ring 392 secures screw 386 in position withm screw housing 390. Screw 386 can be

rotated using a physician's key 394 of the character shown in figure 35 having

spaced apart spanner elements 394a that are receivable with spaced apart aper¬

tures 386a fonned in the head of screw 386. Upon rotation of screw 386. compo¬

nent 388 will be moved downwardly relative to the lower surface of ring 392 so

that a notch 395 fonned thereon (figure 36) will engage one of the circumferen-

tially spaced protuberances 397 formed about the periphery of control component

380. With the control component thus locked against rotation, the rate of infusion

to die patient of the medicinal fluids contained within reservoir 332 cannot be

changed unless and until the physician or caregiver rotates screw 386 in an oppo¬

site direction using the physician's key 394.

Referring next to figures 46 tlirough 53, an alternate fonn of the fluid dis¬

penser assembly of the apparatus of the invention is there shown and generally

designated by the numeral 402. The fluid dispenser component of the apparatus is

somewhat similar to the fluid dispenser illustrated in figures 35 tlirough 45 and like

numerals are used to identify like components. As before, the fluid dispenser

comprises a housing assembly 404 having a base 406. A stored energy source, or

distendable membrane 328 (figure 49) is superimposed over base 406 and, in the

manner previously described, is clamped thereto by a clamping ring 330. A cover

408 of a slightly different design is provided for enclosing the stored energy source and the capture ring Base 406 includes an ullage defining protuberance 406a and

a membrane capture portion 406b Base 406 also includes an upstanding tongue

406c which extends about the perimeter of the base and is closely receivable

within a groove 330b formed in the capture ring 330 When the base and the

membrane capture ring are assembled m the manner shown m figure 49, the pe¬

riphery of distendable membrane 328 will be securely clamped withm groove

330b by tongue 406c

Also foπnmg a part of housing assembly 404 is filling means for filling the

fluid reservoir 332 of the fluid dispenser assembly, which reservoir is defined by

the upper surface of base 406 and the lower surface of distendable membrane 328

This filling means is identical in construction and operation to the previously de¬

scribed fill assembly 334 which includes a fill port 336 which is connected to base

326 and valve means for controlling fluid flow toward reservoir 332

Durmg the reservoir filling step, closure cap 340 is first removed and a fill

line having an appropriate luer connector is connected to fill port 336 This done,

fluid under pressure can be urged to flow into mlet passage ay 342 of the fluid

dispenser via umbrella valve 338 and thence into a reservoir 332 As the fluid un¬

der pressure flows into the reservoir, it will cause membrane 328 to distend

outwardly from protuberance 406a m the manner shown by the phantom lines in

figure 49 In this latest embodiment of the invention, storage means for storing the in¬

fusion means of the apparatus is prov ided in the form of a storage compartment

410 formed in a closure door 412 that is hmgeably connected to a forward housing

portion 414 located proximate the forward end of the dispenser. In addition to

forward housing portion 414, housing 404 includes the previously identified cover

408 and the base 406. Closure door 412 which functions to close the forward end

of the dispenser component is movable about living hinges 417 (figure 47) from

die open position shown in figure 46 to the closed position shown in figures 47 and

49. In the manner indicated in figures 46 and 49, compartment 410 houses the

component parts of the infusion means of the invention, namely the infusion line

348, the gas vent assembly 350, the line clamp 352 and the outlet luer connector

354 (figure 46). The inboard end 348a of infusion line 348 is connected to the

stem portion 420a of a delivery manifold 420 and communicates ith reservoir

332 via an outlet passageway 422 formed m base 406 (figure 50) see also figures

52 and 53). As presently will be described, stem portion 420a includes a fluid pas¬

sageway 421 that communicates with outlet passageway 422 via the novel fluid

flow control means of this latest fonn of the invention.

The novel fluid flow control means of the form of the invention shown in

figures 46 tlirough 53 comprises a flow control assembly 424 which includes a rate

control film 426 that is clamped between apertured clamping plates 428 and 430 As indicated in figure 50, plate 430 fonns a part of a rate control housing 427 with

the shaft portion 430a thereof being rotatably mounted withm a cylindrical bore

429 fonned in base 406 (figure 50). As best seen in figure 48, each of the plates

428 and 430 is provided with a plurality of circumferentially spaced flow apertures

431, which are iiidexably aligned. Apertures 431 are also aligned with laser drilled

areas 434 formed in film 426. An alignment boss 436 (figure 51 ) is formed on film

426 to insure proper alignment of the film with plates 428 and 430. Connected to

shaft 430a proximate its outboard end is a rate control wheel 440. Wheel 440 in¬

cludes a viewing window 440a for viewing flow rate indicia 441 imprinted on de¬

livery manifold 420 (figure 47). With the construction shown, by rotating control

wheel 440 relative to manifold 420, which also causes rotation of the intercon¬

nected plates 428 and 430, each of the laser drilled areas 434 of film 426 can be

moved sequentially into alignment with outlet passageway 422. Because each of

the areas 434 is drilled with one or more microbores of a different, preselected size

preferably ranging from 1 to 100 microns, the rate of fluid flowing outwardly of

the device throughout passageway 422 and into delivery manifold 420 can be pre¬

cisely controlled by positioning a selected area 434 in the flow path between reser¬

voir 332 and delivery manifold 420. Using laser microbore drilling techniques of a

character well known to those skilled in the art, each of the areas 434 can be tai¬

lored to precisely control the rate of fluid flow therethrough. A filter member 426a is disposed between plates 428 and rate control film 426 to prefilter fluid flowing

toward areas 434 (figure 48) As best seen m figure 50, elastomeric O-rings 437

are strategically positioned betw een housing 427 and base 406 to prevent leakage

between the assemblages

With the construction described m the preceding paragraphs, once the fluid

reservoir is appropriately filled, the desired rate of infusion to the patient can be set

by the physician or other caretaker by rotating the control member 440 until the

desired flow rate appears tlirough window 440a Rotation in the opposite direction

is prevented by a blocking tab 421 Once the flow rate is set, a tiireaded locking

number or screw 444, which is threadably connected to control member 440 m the

manner shown in figures 49 and 50 is rotated to secure the control member against

further rotation Locking member 444, which comprises a part of the locking

means of this latest form of the invention, includes spaced-apart apertures 444a

(figure 47) which receive spaced apart spanner elements 394a that are formed on

physician^'s key 394 (figure 35) Upon rotation of screw 444, the tapered end 444b

thereof will be moved inwardly relative to the lower surface of manifold 420 and

into a tapered bore 445 formed in the manifold (figure 50) so as to block further

rotation of control wheel 440 With the contiol wheel thus locked against lotation.

the rate of infusion to the patient of the medicinal fluids contained within l eservon

332 cannot be changed unless and until the physician or caregiver rotates screw 444 m an opposite direction using the phy sician's key 394

Turning next to figures 54 through 60, yet another form of the fluid dis¬

penser assembly of the apparatus of the invention is there illustrated and generally

designated by the numeral 452 The fluid dispenser component of the apparatus is

also somewhat similar to the fluid dispenser illustrated in figures 35 tlirough 45

and like numerals are used to identify like components The fluid dispenser here

comprises a housing assembly 454 having a base 456 A stored energy source, or

distendable membrane 328 (figure 56) is superimposed over base 456 and. m the

manner previously described, is clamped thereto by a clamping ring 330 A cover

331 of identical design to that shown in figures 35 tlirough 45 is provided for en¬

closing the stored energy source and the capture ring Base 456 includes an ullage

defining protuberance 456a and a membrane capture portion 456b Base 456 also

includes an upstanding tongue 456c which extends about the perimeter of the base

and is closely receivable withm a groove 330b formed m the capture ring 330

When the base and the membrane capture ring are assembled m the manner shown

in figure 56, the periphery of distendable membrane 328 will be securely clamped

withm groove 330b by tongue 456c

Also foπnmg a part of housing assembly 454 is filling means for filling the

fluid reservoir 332 of the fluid dispenser assembly which reservoir is defined by

the upper surface of base 456 and the lowei surface of distendable membrane 328 Tins filling means is also identical in construction and operation to the previously

descπbed fill assembly 334 which includes a fill port 336 which is connected to

base 456 and valve means for controlling fluid flow toward reservoir 332

As before, during the reservoir filling step, a closure cap 340 is first removed

and a fill line having an appropriate luer connector is connected to fill port 336

This done, fluid under pressure can be urged to flow into mlet passageway 342 of

the fluid dispenser via umbrella valve 338 and thence into a reservoir 332 As die

fluid under pressure flows into the reservoir, membrane 328 will distend outwardly

from protuberance 456a in the manner shown by the phantom lines in figure 56

In this latest embodiment of the invention, the infusion means of the appa¬

ratus, which is identical to that previously described, is conveniently stored within

the face of forward housing portion 344 One end of infusion line 348 is connected

to base 456 and communicates with reservoir 332 via a base passageway 460 and

outlet passageway 462 In a maimer presently to be described, the novel fluid flow

control means of this latest form of the invention is disposed between the mlet end

of base passageway 460 and the outlet end of outlet passageway 462 (see figure

56)

The novel fluid flow control means of the form of the invention shown in

figures 54 and 60 comprises a flow conti ol assembly 464 which adjustably controls

the rate of fluid flow from the reservon of the apparatus to base passageway 460

o Flow control assembly 464 is mounted withm base 456 and, as best seen m figures

58, 59 and 60, includes a control knob 466 that is i otatably mounted withm flow

control assembly 464 O-πngs 46^" carried by a control knob housing 468 sealably

engage control knob 466 and prevent leakage among the various cooperating com¬

ponents As best seen m figure 60 control knob housing 468 is formed by two co¬

operating parts 468a and 468b withm which the control knob rotates Control knob

housing 468 can be affixed to base 456 by any suitable means such as adhesive

bonding or sonic welding When some welding is used, the housing is provided

with sonic bond energy directors 469 of a character well understood m the art (fig¬

ure 60)

As indicated in figures 57, 58. and 59, control knob 466 includes a central

wall 466a which uniquely carries a plurality of circumferentially spaced apart flow

restrictors each of which can be selectively moved into index with base passage¬

way 460 by rotating knob 466 relativ e to knob housing 468 In the embodiment of

the invention shown m figures 56 through 60, the flow restrictors are provided m

the form of porous rate control frits 470 (see figures 57 and 58), which are secured

m place withm apertures 472 formed m wall 466a by a moldable elastomer 473

under compression fit With the construction shown m the drawings, by rotating

knob 466 relative to housing 468 each of the rate control frits 470 can be moved

sequentially into alignment with base passageway 460 Because each of the frits 470 is of a different, preselected porosity it is apparent that the rate of fluid flow¬

ing outwardly of the device through base or delivery passageway 460 can be pre¬

cisely controlled by positioning a particular frit in the flow path Fluid flowing to¬

ward the rate control means if prefiltered by filter means 462a

As shown in figures 54 and 55, control knob housing 468 includes a v iewing

window 475 for viewing flow rate indicia 477 imprinted on control knob 466

With the construction shown by rotating control knob 466 relative to housing 468,

each of the flow rate indicia imprinted on knob 466 will come into view as die

corresponding rate control frit aligns with delivery passageway 460

With the construction described in the preceding paragraph, once the fluid

by the physician or other care taker by rotating the control knob 466 until the de¬

sired flow rate appears through window 475 Locking member 479, which is

threadably connected to control knob housing 468 m the manner indicated in fig¬

ures 56 and 60 is rotated to secure the control member against further rotation

Locking member 479, which comprises a part of the locking means of this latest

form of the invention, includes spaced-apart apertures 479a (figure 54) which re¬

ceive spaced-apart spanner elements 394a that are fonned on physician's key 394

(figure 35) Upon rotation of screw 479, the inboard end thereof w ill be moved

inwardly relative to housing 468 and into locking engagement with knob 466 so as

-^■2 to block its further rotation. With the control knob thus locked against rotation, the

rate of infusion to the patient of the medicinal fluids contained within reservoir 332

cannot be changed unless and until the physician or caregiver rotates screw 479 in

an opposite direction using the physician's key 394.

In each of the previously described embodiments of the invention, the vari¬

ous materials suitable for use in constructing the base and cover components in¬

clude metals, rubber or plastics that are compatible with the liquids they contact

and are preferably non-allergenic type material. Examples of such materials are:

stainless steel, aluminum, latex rubber, butyl rubber, nitrile rubber, polyisoprene,

styrenebutadine copolymer, silicones, polyolefins such as polypropylene and poly-

ed ylene, polyesters, polyurethane, polyamides and polycarbonates. Suitable mate¬

rials for use in constructing the stored energy means of the invention are described

in incorporated by reference Patent No. 5, 205,820.

Having now described the invention in detail in accordance with the re¬

quirements of the patent statutes, those skilled in this art will have no difficulty in

making changes and modifications in the individual parts or their relative assembly

in order to meet specific requirements or conditions. Such changes and modifica¬

tions may be made without departing from the scope and spirit of the invention, as

set forth in the following claims.

Claims

WE CLAIM:

1. A device for use in infusing medicinal fluid into a patient at a con¬

trolled rate comprising:

(a) a housing having an outlet passageway;

(b) a stored energy means disposed within said housing for forming

a fluid reservoir having an inlet and an outlet in communication with said

outlet passageway of said housing, said stored energy means comprising at

least one generally planar distendable member, said member being distend¬

able as a result of pressure imparted by fluids to establish internal stresses,

said stresses tending to move said member toward a less distended configu¬

ration;

(c) fluid flow control means carried by said housing for controlling

the rate of fluid flow from said reservoir toward said outlet passageway of

said housing, said fluid flow control means comprising a control member

rotatably connected to said housing intermediate said reservoir outlet and

said outlet passageway, said control member having first and second spaced

apart flow restrictors, said control member being rotatable from a first posi¬

tion wherein said first flow restrictor is aligned with said outlet of said reser¬

voir and said outlet passageway and a second position wherein said second flow restrictor is aligned with said outlet of said reservoir and said outlet

passageway.

2. The device as defined in claim 1 in which said control member com¬

prises a shaft and in which said first and second flow restrictors comprise first and

second spaced-apart porous frits mounted in said shaft.

3. The device as defined in claim 1 in which said control member com¬

prises a film and in which said flow restrictors comprise first and second spaced-

apart porous areas of said film.

4. The apparatus as defined in claim 1 in which said control member

comprises a disk and in which said first and second flow restrictors comprise

spaced-apart porous frits mounted in said disk.

5. The device as defined in claim 1 further including infusion means in

communication with said outlet passageway of said housing for infusing medicinal

fluid into a patient.

6. The device as defined in claim 5 in which said housing further in¬

cludes storage means for storing said infusion means.

7. The apparatus as defined in claim 5 further including filling means in

communication with said reservoir for filling said reservoir with medicinal fluid.

8 The device as defined m claim 7 in which said filling means com¬

prises a fill port connected to said housing and val e means disposed withm said

housing for controlling fluid flow between said fill port and said reservoir

9 A device for use in infusing medicinal fluid into a patient at a con¬

trolled rate comprising

(a) a fluid dispenser including

(I) a housing having a base,

(u) a stored energy means for forming, m conjunction with

said base, a fluid reservoir having an mlet and an outlet, said stored

energy means comprising at least one distendable member superun-

posed over said base, said member being distendable as a result of

pressure imparted by the fluids to be infused to establish internal

stresses, said stresses tending to move said member toward a less dis¬

tended configuration,

(in) an outlet passageway formed in said base for communi¬

cation with said outlet of said fluid reservoir,

(b) fluid flow control means carried by said base for controlling the

rate of fluid flow from said reservoir toward said outlet passageway, said

fluid flow control means comprising a control member rotatably connected

to said base intermediate said lesei von outlet and said outlet passageway, said control member having first and second spaced apart flow restrictors,

said control member being rotatable from a first position wherein said first

flow restrictor is aligned with said outlet of said reservoir and said outlet

passageway and a second position wherein said second flow restrictor is

aligned with said outlet of said reservoir and said outlet passageway; and

(c) infusion means in communication with said outlet passageway

for infusing fluid from said reservoir into the patient.

10. The device as defined m claim 9 further including filling means con¬

nected to said housing for filling said reservoir.

11. The device as defined in claim 9 in which said control member com¬

second spaced-apart, radially extending, porous frits mounted in said shaft.

12. The device as defined in claim 9 in which said control member com¬

prises a film and in which said flow restrictors comprise first and second circum¬

ferentially spaced porous areas of said film.

13. The apparatus as defined in claim 9 in which said control member

comprises a disk and in which said first and second flow restrictions comprise cir¬

cumferentially spaced-apart porous frits mounted in said disk.

14 The device as defined in claim 9 in which said filling means com¬

prises a fill port connected to said housing and means disposed w itlim said housing

for controlling fluid flow between said fill port and said reservoir

15. The device as defined m claim 9 further including locking means for

locking means for locking said control member against rotation.

16. The device as defined in claim 15 in which said locking means com¬

prises a direaded member tlireadably connected to said base for rotation between a

first position wherein said control member is locked against rotation and a second

position wherein said control member is rotatable.